Acquired immune deficiency syndrome ("AIDS") is a disease thought most likely to be caused by the human immunodeficiency virus ("HIV"). The main targets of HIV are two different cells, the T4 lymphocyte and the macrophage. Once infected the T4 lymphocyte population generally begins to decline. Unlike the T4 lymphocytes, the macrophage is not killed by HIV infection but may actually serve as a reservoir for the virus. Gallo & Montagneir "AIDS in 1988", Scientific American, p. 25 (October 1988).
The early diagnosis of persons suffering from HIV infection generally involves using diagnostic tests to determine whether or not a person has antibodies to HIV. Early diagnosis is especially important in HIV infection as it enables the patient to receive optimal medical care from the earliest moments of the disease and to check further spread of the contagion. Redfield & Burke "HIV Infection: The Clinical Picture", Scientific American, p. 70.
European Patent application 219,368 A (corresponding to U.S. patent application Ser. No. 07/298,791) discloses certain monoclonal antibodies directed against proteins which form constituent parts of the "prosome". Prosomes are cellular particles described in Schmid et al "The prosome: an ubiquitous morphologically distinct RNP particle associated with repressed mRNPs and containing specific ScRNA and a characteristic set of proteins,", The EMBO Journal, 3(1), 29-34 (1984).
The prosome has been also variously called the "proteasome" or "mcp" (multicatalytic protease). European Patent application 0 345 750 A2 discloses a "polyfunctional protease", and antibodies thereto. The polyfunctional protease described in this application may be the prosome.
Since early 1990, mouse monoclonal antibodies against prosomal proteins have been commercially available from Organon Teknika nv of Turnhout, Belgium. The commercially available monoclonal antibodies have been ones directed against prosomal proteins p23K, p25K, p27K, p29K (p28K, p33K), p30/33K, and p31K and the anti-p21K ("prosome-like particle"). These antibodies are more thoroughly described in Research Reagent News, (January 1990) available from Organon Teknika nv.
In EP 219,368 A1, it is also disclosed that prosomes may be involved in many physiological processes related to the differentiation of cells and organisms, communication between cells, and to autoimmune disease. Also disclosed is that monoclonal antibodies directed against prosomes can be useful in the diagnosis of, for example, cancer.
In Research Reagent News, disclosed uses for the monoclonal antibodies against the prosomal proteins include the study of the molecular biology of prosomes, the distribution of specific types of prosomes in normal and pathological cells and tissues, messenger and other ribonucleoproteins.
No where is it described or suggested that any of these anti-prosomal proteins monoclonal antibodies might have any possible usefulness in the diagnosis of infectious diseases such as AIDS or HIV infection.